The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
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The patient was undergoing a coil embolization procedure for a type ii endoleak repair using a lantern delivery microcatheter (lantern).During the procedure, while advancing a lantern into the aneurysm sac, the physician did not encounter much resistance but was navigating through calcium and thrombus.While navigating through the calcium, the physician inadvertently bent the distal tip of the lantern.Therefore, the lantern was removed and the procedure was completed using a new lantern.There was no report of an adverse effect to the patient.
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